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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  04/30/2008
 
Trade Name:  Cardiolite
 
Generic Name or Proper Name (*):  technetium tc99m sestamibi
 
Indications Studied:  Medical imaging in Kawasaki disease
 
Label Changes Summary:  * Safety and effectiveness have not been established in the pediatric population * No evidence of diagnostic efficacy or clinical utility of scan was found in 3 clinical studies of children and adolescents with Kawasaki disease * A study of 445 pediatric patients failed to demonstrate the predictive value of Cardiolite rest and stress myocardial perfusion imaging to define children with Kawasaki disease at risk of developing cardiac events 6 months after receiving Cardiolite; only 3cardiac events were observed. In all 3 cases, the scan was negative * Adverse events similar to that of adults * Information on dose, PK, and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Lantheus Medical Imaging
 
Pediatric Exclusivity Granted Date:  01/11/2008
 
NNPS:  FALSE
 
Therapeutic Category:  Diagnostic aid
 
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